An ADME Study of [14C]-ITI-1284 in Healthy Subjects (QSC301823)
Research type
Research Study
Full title
A Phase 1, Open-label Study to Assess the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of a Single Subcutaneous Dose of [14C]-ITI-1284 in Healthy Male Subjects
IRAS ID
1010439
Contact name
Antonia Periclou
Contact email
Sponsor organisation
Intra-Cellular Therapies, Inc.
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, ITI-1284, for the treatment of central nervous system disorders.
In this study, we’ll give healthy volunteers a single dose of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ - it will contain a small amount of radioactivity (Carbon-14) - so that we can track it in the body. We also want to get more information on the safety and tolerability of the test medicine and any side effects.
This study will take place at 1 site in Nottingham. We plan to enrol 8 healthy men aged 30 to 55 years.
Volunteers will receive a single dose of radiolabelled test medicine, by a single injection or 2 injections under the skin of the belly. They’ll stay in the clinic for 14 nights, attend up to 2 return visits (an overnight stay each) if required and 1 end of study visit, and take up to 7 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 14 days, we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0763
Date of REC Opinion
23 Jan 2025
REC opinion
Further Information Favourable Opinion